BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONORAIL MAVERICK 2

    MDR report key: 1101563 · Received July 25, 2008

    Report

    Report Number
    1101563
    Event Type
    Malfunction
    Date Received
    July 25, 2008
    Date of Event
    June 19, 2008
    Report Date
    July 7, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LOX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BALLOON RUPTURED AT 10 ATM. NO UNTOWARD EFFECT ON THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONORAIL MAVERICK 2 CATHETER, BALLOON DILATATION LOX BOSTON SCIENTIFIC * 11579148

    Patients

    Seq Age Sex Outcome Treatment
    1 *